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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problem Tissue Breakdown (2681)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced a skin breakdown (date not reported) and subsequently the patient was underwent skin revision surgery on (b)(6) 2023.Additional information has been requested but has not been made available as of the date of this report.
 
Event Description
It was also reported that the patient was placed under general anesthesia on (b)(6) 2023.
 
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Brand Name
ASKU
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW  435 33
MDR Report Key18000526
MDR Text Key326444714
Report Number6000034-2023-03439
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/17/2023,10/26/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2023
Distributor Facility Aware Date10/26/2023
Event Location Hospital
Date Report to Manufacturer10/26/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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